Won Ji Eon, Chu Ji Yeon, Choi Hyunah Caroline, Chen Yun, Park Hyun Jun, Dueñas Héctor José
Lilly Korea, Seoul, South Korea.
Lilly Suzhou Pharmaceutical Company, Shanghai, China.
World J Mens Health. 2018 May;36(2):161-170. doi: 10.5534/wjmh.17017. Epub 2017 Sep 6.
The aim of this study was to investigate the safety and effectiveness of tadalafil 5 mg once daily (quaque die [everyday], QD) among Korean men with benign prostatic hyperplasia (BPH)/lower urinary tract symptoms (LUTS) in a real-world clinical setting.
This was a single-country, prospective, observational cohort study in which patients newly prescribed tadalafil 5 mg QD for the treatment of BPH/LUTS were followed-up for 12±2 or 24±2 weeks, or to the last treatment, during post-marketing surveillance. Safety was evaluated in terms of the frequency of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). Effectiveness was assessed by changes in the International Prostate Symptom Score (IPSS) from baseline to each endpoint.
All patients receiving ≥1 dose of tadalafil 5 mg QD (N=637) were included in the safety population. Two percent of patients (n=13) experienced 15 TEAEs of mild (n=10; 66.7%) or moderate (n=5; 33.3%) severity. No severe TEAEs and no SAEs were reported. Effectiveness evaluations included all patients receiving tadalafil who had both baseline and endpoint observations (12-week, N=265; 24-week, N=44). Compared with baseline, the mean IPSS total score (±standard error) significantly improved by 4.7±0.3 and 6.4±0.7 points at the 12- and 24-week endpoints, respectively (p<0.0001), with significant improvements also observed on the storage, voiding, and quality of life subscores. In total, 69.1% of the patients had a clinically meaningful ≥3-point improvement in the IPSS total score.
Tadalafil 5 mg QD was well tolerated and effective in Korean men with BPH/LUTS in a real-world clinical setting.
本研究旨在调查在真实临床环境中，每日一次服用5毫克他达拉非（每日一次，QD）对患有良性前列腺增生（BPH）/下尿路症状（LUTS）的韩国男性的安全性和有效性。
这是一项单国家、前瞻性、观察性队列研究，在上市后监测期间，对新开具每日一次5毫克他达拉非用于治疗BPH/LUTS的患者进行了12±2或24±2周的随访，或直至最后一次治疗。通过治疗出现的不良事件（TEAE）和严重不良事件（SAE）的发生频率评估安全性。通过国际前列腺症状评分（IPSS）从基线到每个终点的变化评估有效性。
所有接受≥1剂每日一次5毫克他达拉非的患者（N = 637）被纳入安全性人群。2%的患者（n = 13）经历了15次轻度（n = 10；66.7%）或中度（n = 5；33.3%）严重程度的TEAE。未报告严重TEAE和SAE。有效性评估包括所有接受他达拉非治疗且有基线和终点观察数据的患者（12周时，N = 265；24周时，N = 44）。与基线相比，在12周和24周终点时，IPSS总分（±标准误差）分别显著改善了4.7±0.3和6.4±0.7分（p < 0.0001），在储尿、排尿和生活质量子评分方面也观察到显著改善。总体而言，69.1%的患者IPSS总分有临床意义的≥3分改善。
在真实临床环境中，每日一次服用5毫克他达拉非对患有BPH/LUTS的韩国男性耐受性良好且有效。
